A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy of Daridorexant on Nighttime Symptoms and Daytime Functioning in Adult and Elderly Participants With Insomnia Disorder
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 344
- 主要终点
- Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)
研究概览
简要总结
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.
The trial aims to find out whether daridorexant can help improve:
- how trial participants sleep at night,
- how trial participants function the next day.
Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning.
Enrolled participants will:
- Take daridorexant 50 mg or placebo once daily for approximately 3 months
- Visit the clinic once every month during treatment for checkups and tests
- Keep a sleep diary of the number of hours they sleep and how well they sleep
- Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.
详细描述
The trial includes three trial periods:
Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 1:1 ratio to receive either daridorexant 50 mg or placebo for ca. 3 months (Treatment period). On completion of treatment, participants will be followed for up to 10 days for safety assessments (Safety follow-up period).
Trial participation will end with a Follow-up call (Participant Last Visit) at the end of the Safety follow-up period.
The maximum trial duration for an individual participant will be approximately 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥ 18 years at the time of signing the ICF
- •Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit
- •Insomnia Severity Index© score ≥ 15
- •Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening
- •Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above
排除标准
- •Body mass index < 18.5 or > 40.0 kg/m2
- •Any lifetime history of breathing-related sleep disorder
- •Presence of an additional sleep-wake disorder
- •Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week
- •Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1
- •Acute or unstable (i.e., not adequately controlled for at least 1 month) psychiatric condition
- •Any suicidal ideation or history of suicide attempt, as assessed by Columbia Suicide Severity Rating Scale© (C-SSRS©), at Visit 1
- •Unstable medical condition, which, in the opinion of the investigator, could affect the participant's safety or interfere with the trial assessments
研究组 & 干预措施
Placebo
Participants will receive placebo orally, once daily for approximately 3 months.
干预措施: Placebo (Drug)
Daridorexant
Participants will receive 50 mg daridorexant orally, once daily for approximately 3 months.
干预措施: Daridorexant (Drug)
结局指标
主要结局
Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)
时间窗: Baseline and Month 3
Subjective Total Sleep Time (sTST) is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. A negative change from baseline indicates a decrease in sTST.
次要结局
- Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS)(Baseline and Month 3)
- Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS)(Baseline and Month 3)